ACAM2000® Myopericarditis Registry

Emergent BioSolutions

Status: Completed

Conditions: Pericarditis; Myocarditis

Study type: Observational

Funder types: Industry

Identifiers

NCT01395082

U1111-1120-1721 (Other Identifier)

H-406-003

Details and patient eligibility

About

The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.

Primary Objective:

• To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.

Other Pre-defined Objective:

• To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.

Full description

All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).

Enrollment: 24 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
• Documented vaccination with ACAM2000® vaccine
• Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.

Exclusion criteria

• Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.

Trial design

24 participants in 1 patient group

Entire registry group

Description:

Participants with potential myopericarditis cases referred to the Registry